Beta Cell Function and Related Pharmacodynamics of HMS5552 in T2DM Patients
- Registration Number
- NCT02386982
- Lead Sponsor
- Hua Medicine Limited
- Brief Summary
This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Male and female,age 18-65 years
- Has type 2 diabetes mellitus
- BMI 20 to 29kg/m2
- Willingness to adhere to the protocol requirement
Exclusion Criteria
- Patients with type1 diabetes mellitus
- Received any antidiabetic drug within run-in or during screening
- Hepatic diseases
- Kidney diseases
- Clinical abnormal finding in EVG,labs and physical exams
- Women of child-bearing potential
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HMS5552 dose 2 HMS5552 HMS5552 75mg.Oral administration,once per day. HMS5552 dose 1 HMS5552 HMS5552 75mg.Oral administration,twice per day.
- Primary Outcome Measures
Name Time Method beta cell function 4 weeks will be assessed by change of beta cell function index
24-hour glucose change 4 weeks HbA1 4 weeks
- Secondary Outcome Measures
Name Time Method The study drug concentration in blood samples to be collected after drug administration 4 weeks Composite measure of adverse events monitoring, physical examinations,12 lead ECGs, vital sign,and safety laboratory measurement 4 weeks
Trial Locations
- Locations (1)
The 1st Betuhune Hospital of Jilin University
🇨🇳Changchun, China